Kosmos Accessories - US P006208
by EchoNous
Kosmos Accessories - US P006208 is a Class II device made by EchoNous, cleared under FDA 510(k) K193518 on 26 Mar 2020 and listed in FDA GUDID since 6 May 2020 (UDI-DI 09353278000267), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number09353278000267 | Date6 May 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK193518 | Date26 Mar 2020 | StatusActive |
Official records
- AccessGUDID record 09353278000267
- FDA 510(k) database K193518
Across registries
- FDA 510(k) K193518 decided 26 Mar 2020 Active
- FDA GUDID UDI-DI 09353278000267 listed 6 May 2020 Listed
Timeline
- Cleared FDA 510(k) K193518
- Listed FDA GUDID 09353278000267
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Kosmos Accessories - US
- Generic name
- Electrocardiograph, professional, single-channel
- Model / reference
- P006208
- Primary DI / UDI-DI
- 09353278000267
- 510(k) Number
- FDA product code
- DQD, DPS
- GMDN term
- Electrocardiograph, professional, single-channel
- Device class
- Class II
- Regulation number
- 870.1875, 870.2340
- GUDID distribution status
- In Commercial Distribution
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